Efficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis.

- candidate number

2156

- NTR Number

NTR725

- ISRCTN

ISRCTN07263575

- Date ISRCTN created

28-sep-2006

- date ISRCTN requested

27-sep-2006

- Date Registered NTR

3-jul-2006

- Secondary IDs

N/A

- Public Title

Efficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis.

- Scientific Title

Efficacy of Inhaled RhDNase in Mechanically Ventilated Pediatric Patients with an Atelectasis.

- ACRONYM

N/A

- hypothesis

RhDNase can liquefy mucus in children with an atelectasis during mechanical ventilation, resulting in improved mucociliary clearance, less mucus retention and less airways obstruction, thereby enhancing the rate of resolution of an atelectasis. Moreover we expect the ventilator settings, pulmonary ventilation and ventilation-perfusion mismatch to improve faster, possibly resulting in a shorter time spent on a ventilator and on the ICU.

1. Age 0-18 years;
2. Mechanical ventilation;
3. Presence of an atelectasis on a chest radiograph;
4. First dose of study medication can be administered preferably within 6 hours (max 12 hours) after an atelectasis has been diagnosed.

- Exclusion criteria

1. Children with neuromuscular disorders and impaired ability to cough; cardiomyopathy; or cystic fibrosis;
2. Post-gestational age < 32 weeks;
3. Mechanical ventilation during muscle paralysis;
4. Atelectasis due to a bronchoscopically diagnosed:
- foreign body aspiration;
- tracheal or bronchial compression by lymph nodes or vessels;
5. Recurrent atelectasis due to an anatomical airway-abnormality;
6. RhDNase treatment in the previous 48 hours;
7. Clinical condition or ventilator settings that are not compatible with nebulizing medication (according to the responsible physician);
8. Presence of a pneumothorax;
9. Previous participation in the study.

Atelectasis in children during mechanical ventilation often results from and/or is associated with airway inflammation and airways infection, with an increased influx of inflammAatory cells in the airways. Inflammatory cells and damaged epithelial cells degrade, and release DNA in airway mucus resulting in an increased mucus viscosity. Viscous mucus impairs mucociliary clearance, resulting in airways obstruction and impaired resolution of atelectasis.

We therefore designed a study to evaluate the efficacy of the mucolytic medicine rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.